Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients

NCT03684993 | Completed Phase 2

• 1 other identifier: arabic gum licorice CHX
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is to test the caries prevention effect of Arabic gum and Licorice root extracts compared to Chlorhexidine in high caries risk patients. The antimicrobial efficacy and oral side effects from using these mouthwashes will also be tested.

Conditions

High Caries Risk Patients; Caries; Antimicrobial Effect; Side Effect

Outcome Measures

Primary Outcomes (1)

• Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera

  development of new caries lesions. Clinical examination during study time to Measure DMF scoring index: any changes in number of decayed, missing and filled surfaces due to caries from baseline. Done according to International Caries Detection and Assessment System (ICDAS II criteria)

  1 year (detected after 3, 6, 9 and 12 months)

Secondary Outcomes (2)

• Antimicrobial efficacy - Incubating agar plates - Colony forming units (CFU/mL)

  1 year (evaluated after 3, 6, 9 and 12 months)

• Side (Adverse) effect - subjective: Reporting Questionnaire - Binary outcome (yes/no)

  1 year (recorded after each month of mouthwash use)

Study Arms (3)

Arabic gum extract

EXPERIMENTAL

natural product Arabic gum (acacia gum) prepared as a mouthwash

Drug: Arabic, Gum

Licorice root extract

EXPERIMENTAL

natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash

Drug: Licorice Root

Chlorhexidine

ACTIVE COMPARATOR

chemical agent Chlorhexidine as a mouthwash

Drug: Chlorhexidine

Interventions

Arabic, Gum DRUG

natural gum of acacia tree: Antimicrobial, anti-inflammatory medicinal plant used as a traditional oral hygiene substance (anticariogenic). It is used in treating sore throats, colds, bronchitis, toothache, gingival bleeding and mouth ulcers.

Also known as: acacia gum

Arabic gum extract

Licorice Root DRUG

natural licorice, herbal plant to relieve coughs, sore throats, and gastric inflammation. flavouring and sweetening agent. it's anti-caries, soothing anti-inflammatory and anticancer properties benefit against oral diseases and dental caries

Also known as: Glycyrrhiza Glabra

Licorice root extract

Chlorhexidine DRUG

chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard

Also known as: Chlorhexidine gluconate or Chlorhexidine HCL

Chlorhexidine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• High caries risk patients according to CAMBRA caries risk assessment tool
• Baseline of at least 2-3 active non-cavitated or cavitated carious lesionssz
• Baseline salivary Mutans streptococci count ≥ 106 CFU/ml
• Baseline salivary Lactobacilli count ≥ 104 CFU/ml
• Baseline DMF index of at least 3-5
• Cooperative patients approving to participate in the study

You may not qualify if:

• Any systemic conditions, severe medical complications
• Significant past or current medical condition that may affect oral health or oral flora
• Current medications (may affect the oral flora or salivary flow)
• Allergy to any of the ingredients of the study products
• Use of any antibiotics within the past 3 months
• Use of any mouth rinses within the past 3 months
• Current periodontitis (sites of probing pocket depth ≥ 5 mm)
• Evidence of parafunctional habits
• Dysfunction of temporomandibular joint
• Presence of developmental dental anomalies
• Presence of orthodontic appliance or removable prosthesis
• Pregnancy
• Xerostomia
• Heavy smoking
• Drug or alcohol addiction, or conditions that may decrease adhering to study protocol

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 12411, Egypt

Location

Related Publications (5)

• Gupta D, Gupta RK. Investigation of antibacterial efficacy of Acacia nilotica against salivary mutans streptococci: a randomized control trial. Gen Dent. 2015 Jan-Feb;63(1):23-7.

  PMID: 25574715 BACKGROUND

• Hu CH, He J, Eckert R, Wu XY, Li LN, Tian Y, Lux R, Shuffer JA, Gelman F, Mentes J, Spackman S, Bauer J, Anderson MH, Shi WY. Development and evaluation of a safe and effective sugar-free herbal lollipop that kills cavity-causing bacteria. Int J Oral Sci. 2011 Jan;3(1):13-20. doi: 10.4248/IJOS11005.

  PMID: 21449211 BACKGROUND

• Chandra Shekar BR, Nagarajappa R, Singh R, Thaku R. Antimicrobial efficacy of the combinations of Acacia nilotica, Murraya koenigii L. sprengel, Eucalyptus hybrid and Psidium guajava on primary plaque colonizers. J Basic Clin Pharm. 2014 Sep;5(4):115-9. doi: 10.4103/0976-0105.141954.

  PMID: 25316992 BACKGROUND

• Almaz ME, Sonmez IS, Okte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30.

  PMID: 27129589 BACKGROUND

• Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964.

  PMID: 24021323 BACKGROUND

MeSH Terms

Interventions

Gum Arabic; Glycyrrhiza glabra extract; Chlorhexidine; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 26, 2018
• Study Start: December 10, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)